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A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
NCT06888193 · UCB Pharma
In plain English
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Official title
A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
About this study
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
Eligibility criteria
Inclusion Criteria:
* Study participant must be at least 18 years of age at the time of signing the informed consent.
* Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician.
* Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period.
* The decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study.
* Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting/restarting/continuing bimekizumab prior to sampling (prior to start of the Sampling Period).
* A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study.
Exclusion Criteria:
* Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
* The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or compromise study participation.
* Study participant has a history of chronic alcohol or drug abuse within the previous last year.
* Study participant has history of breast implants, breast augmentation, or breast reduction surgery.
* Study participant plans a surgical intervention during the Screening Period and Sampling Period or anticipates having surgery while participating in the Sampling Period (does not apply to tubal ligation).
* Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device) within the previous 6 months or is currently participating in another study of an IMP (and/or an investigational device), unless the study is UCB PS0036 or a bimekizumab registry study.
* Study participant or her infant has previously participated (ie, entered the sampling period) in this study.
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-05
Estimated completion: 2027-05-03
Last updated: 2026-07-17
Interventions
Drug: Bimekizumab
Primary outcomes
- • Concentration of bimekizumab in the breast milk on Day 1 (Day 1)
- • Concentration of bimekizumab in the breast milk on Day 2 (Day 2)
- • Concentration of bimekizumab in the breast milk on Day 3 (Day 3)
Sponsor
UCB Biopharma SRL · industry
Contacts & investigators
ContactUCB Cares · contact · ucbcares@ucb.com · 1-844-599-2273 (USA)
ContactUCB Cares · contact · ucbcares@ucb.com · 001 844 599 2273 (USA)
InvestigatorUCB Cares · study_director, 001 844 599 2273
All locations (14)
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Santa Monica, California, United States
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South Miami, Florida, United States
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Boston, Massachusetts, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Milwaukee, Wisconsin, United States
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Calgary, Canada
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Vancouver, Canada
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Freiburg im Breisgau, Germany
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Herne, Germany
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Barcelona, Spain
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Barcelona, Spain
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Lausanne, Switzerland
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Sankt Gallen, Switzerland